The Shift Engineer will be responsible for the use of process engineering systems and approaches during processing shifts for monitoring equipment and process performance
Job Summary
The Shift Engineer will be responsible for the use of process engineering systems and approaches during processing shifts for monitoring equipment and process performance.
The role will involve being a key point of contact and liaison between Manufacturing Operations and Manufacturing Technical Support, working as part of a team of scientists, engineers and support specialists.
Responsible for the generation and approval of GMP documentation to support compliance and regulatory expectations for manufacturing operations.
Matching Summary
The Shift Engineer will be responsible for the use of process engineering systems and approaches during processing shifts for monitoring equipment and process performance.
Skills & Requirements
Must-have
Process engineering systems
Real-time process monitoring
Troubleshooting
cGMP Guidelines
Electronic Batch Records
Standard Operating Procedure (SOP) Writing
Sterile Manufacturing
Nice-to-have
Continuous improvement methodologies
Collaboration, negotiation, conflict resolution
Global regulatory experience
Interfacing with regulators
Key Requirements
Minimum Level 8 qualification or equivalent industrial experience
3-5 years experience in regulated pharmaceutical manufacturing
Demonstrated understanding of continuous / process improvement tools
Exceptional analytical, problem solving & root-cause analysis skills